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ORBITAL: Open-Label Primary C...

ORBITAL: Open-Label Primary Care Study: Rosuvastatin Based Compliance Initiatives Linked To Achievement Of LDL Goals

Last Updated: 2009-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Total Enrollment

1294 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-02-28

Brief Summary

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24 week open label study to compare the treatment either with rosuvastatin or rosuvastatin plus initiatives to improve compliance. If the subject does not reach the EAS LDL-C treatment goal at week 12, rosuvastatin will be titrated from 10mg to 20mg.

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Detailed Description

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Conditions

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Primary Hypercholesterolaemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Rosuvastatin

Intervention Type DRUG

Initiatives to improve compliance

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Primary hypercholesterolaemia:
* Statin naïve subjects (LDL-C level \> 3.5 mmol/L) or subjects on an ineffective "start dose" of a lipid-lowering therapy (LDL-C level \> 3.1 mmol/L).
* CV risk \> 20%,
* history of CHD or other established atherosclerotic disease

Exclusion Criteria

* History of severe adverse events with another HMG-CoA reductase inhibitor
* Secondary hypercholesterolaemia;
* Unstable cardiovascular disease;
* Uncontrolled diabetes, active liver disease;
* Severe hepatic or renal impairment;
* Treatment with cyclosporin.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers